Pharmaceutically acceptable starch
AssigneeJagotec AG
InventorsNils Ove Gustavsson, Monica Jonsson, Per Berden, Timo Laakso
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Abstract
Production of purified, parenterally administrable starch by washing starch containing more than 85% amylopectin in order to remove surface-localized proteins, lipids and endotoxins, dissolving the starch in aqueous medium, molecular weight reduction by shearing, and optionally removal of residual water-soluble proteins, preferably by anion exchange chromatography. Purified starch and microparticles based on such starch.
Claims45
A process for the production of a starch that is pharmaceutically acceptable, especially for parenteral administration, for example by means of injection, to a mammal, especially a human, which comprises
- a) starting from starch in solid form, especially particles, for example granules, and with an amylopectin content in excess of 85 percent by weight, expressed as dry weight of starch,
- b) subjecting said solid starch to washing(s) under conditions such that proteins, lipids and endotoxins surface-localized on the starch are dissolved whilst the starch remains undissolved, and separating the starch from the dissolved material,
- c) causing the washed starch obtained from step b) to dissolve in an aqueous medium, and
- d) subjecting the starch solution to a molecular weight reduction by shearing such that a molecular weight distribution is obtained in which at least 80 percent by weight of the material lies within the range of 10-10000 kDa.
A pharmaceutically acceptable starch, especially for parenteral administration, preferably by way of injection, to a mammal, especially a human, which
- a) has an amylopectin content in excess of 85 percent by weight, in which the molecular weight of said amylopectin has been reduced, preferably by shearing so that at least 80 percent by weight of the material lies within the range of 10-10,000 kDa,
- b) has a purity of at most 50 μg amino acid nitrogen per gram dry weight of starch, preferably at most 20 μg, more preferably at most 10 μg, and most preferably at most 5 μg, amino acid nitrogen per gram dry weight of starch,
- c) can be dissolved in a concentration exceeding 25 percent by weight in water.
A pharmaceutically acceptable starch, especially for parenteral administration, preferably by way of injection, to a mammal, especially a human, which
- a) has an amylopectin content in excess of 85 percent by weight, in which the molecular weight of said amylopectin has been reduced, preferably by shearing so that at least 80 percent by weight of the material lies within the range of 10-10000 kDa,
- b) has a purity of at most 50 μg amino acid nitrogen per gram dry weight of starch, preferably at most 20 μg amino acid nitrogen, more preferably at most 10 μg, and most preferably at most 5 μg amino acid nitrogen per gram dry weight of starch,
- c) lacks covalently bonded additional chemical groups of the type that occur in hydroxyethyl starch.
Dependencies are inferred from the claim text.